About this trial
Neonatal jaundice, or neonatal hyperbilirubinemia, is a common medical issue in the first two weeks of life, causing prolonged hospitalization and readmissions. It results from elevated total serum bilirubin (TSB) and is manifested as yellowish discoloration of the skin, sclera, and mucous membrane. Clinical jaundice appears in about 60% of term neonates and 80% of preterm infants within the first week of life. Pathologic hyperbilirubinemia occurs when bilirubin levels increase by more than 5 mg/dL/day or 0.2 mg/dL/hour, or when jaundice lasts longer than two to three weeks in full-term infants. In preterm infants, unconjugated hyperbilirubinemia is of particular concern due to their permeable blood-brain barrier and underdeveloped brain. Phototherapy is widely used to reduce or prevent the rise of serum unconjugated bilirubin levels and reduce the need for exchange transfusions. However, phototherapy has both immediate and long-term side effects, and it can only decrease accumulated UCB but does not prevent its accumulation. There is a growing potential to explore novel adjuvant treatments to increase bilirubin clearance, decrease phototherapy duration, and decrease exchange transfusion rate.
Eligibility criteria
Qualifiers
neonates with both genders
neonates with gestational age ≥ 32 weeks
neonates who can tolerate enteral feeding
diagnosed with unconjugated non-hemolytic hyperbilirubinemia
Disqualifiers
Neonates with seizures, hydrops fetalis, hypoxic-ischemic encephalopathy, or major congenital anomalies
Neonates who have had an exchange transfusion within 24 hours
neonates have evidence of hemolytic causes of jaundice (e.g., ABO and RH
incompatibility, glucose 6-phosphate dehydrogenase deficiency)
Trial design
Treatments tested in this trial
- Zinc sulfate
- Ursodeoxycholic acid
Treatment groups
8
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Amira Adel Fouly
Lead sponsor
Future University in Egypt
Sponsor institution
Egyptian Chinese University
Collaborator
Ain Shams University
Collaborator